VIDA study

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Expanded clinical use of CIGB-258 in the treatment of serious or critically ill patients by COVID-19 (COVID-19)

Secondary indentifying numbers:

IG/CIGB-258/UCE

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, Cuba.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Rafael

Last name:

Venegas Rodriguez

Medical Specialty :

1st degree specialist in Intensive Medicine

Affiliation:

“Luis Diaz Soto” Hospital

Postal address:

Ave Monumental Km 2 ½

City:

Havana

Country:

Cuba

Zip Code:

19130

Telephone:

+53-77680715

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, “Salvador Allende” Hospital, Alejandro Martinez Adan, 1st degree Specialist in Intensive Medicine.

Matanzas, Hospital "Mario Muñoz Monroy", Fidel Sanchez Villanueva, 1st degree Specialist in Epidemiology.

Villa Clara, "Celestino Hernandez Robau" Hospital, Reinier Rodriguez Alonso, 1st degree Specialist in Intensive Medicine.

Holguin, "Fermin Valdes Dominguez" Hospital, Joanne Leslie Graña Mir, 1st degree Specialist in Intensive Medicine.

Isla de la Juventud, "Heroes de Baire" Hospital, Inurkis Correa Palmero, 1st degree Specialist in Hematology.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

27/04/2020

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

COVID-19 respiratory distress

Intervention(s):

- Patients WITH invasive mechanical ventilation, CIGB-258 Peptide: 1 mg intravenously until extubation of the patient. Subsequently, the same dose and route is continued, every 24 hours, for three days. If there is no clinical, gasometric and radiological improvement after 72 hours, the dose may be increased to 2 mg, with a frequency of 12 hours (at the discretion of the physician). Never exceed 4 mg daily. - Patients WITHOUT invasive mechanical ventilation, CIGB-258 Peptide: 1 mg intravenously 1 mg every 24 hours until the patient reverses his condition (that is, that he does not require oxygen therapy and there are no signs and / or symptoms of acute respiratory failure). In case of unfavorable evolution and need for mechanical ventilation, the CIGB-258 therapeutic scheme is modified every 12 hours, detailed above (for patients with invasive mechanical ventilation).

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Reduction of the deterioration of the pulmonary function (Proportion of patients that did not require increasing FiO2 to maintain stable SO2 and without the need for intubation and / or Percentage of patients that decrease the values of positive pressure at the end of expiration [PEEP]). Measurement time: On the 7th day after starting the treatment.

Key secondary outcomes:

1) Mortality upon discharge from the ICU (proportion of patients who die, according to their causes). Measurement time: during the stay at the Intensive Care Unit. 2) Need and time for mechanical ventilation (Yes, No; time in days elapsed from the start date of ventilation until weaning). Measurement time: During the stay in intensive care, until ventilatory weaning. 3) Measurement of hyperinflammation score parameters (temperature, visceromegaly, cytopenia, triglycerides, aspartate aminotransferase - TGO, fibrinogen, ferritin). Measurement time: at the beginning, at hours 48 and 72, as well as on the 5th and 7th day after starting the treatment. 4) Stay in intensive care-ICU (Time in the ICU from the start of treatment until discharge). Measurement time: during ICU stay. 5) Behavior of biomarkers (Absolute lymphocyte count, C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase-LDH and D-dimer). Measurement time: at the beginning, at hours 48 and 72, on the 5th and 7th day. 6) Adverse clinical events-AE (They will be measured as: -Adcurrence of AE [Yes, No], -Description of the AE [name of the event], -Intensity of the AE [mild, moderate, severe], -Relation of causality [no related, doubtful, possible, probable, definitive] -Measures taken [None, Administration of some pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization], -Result [Fully resolved, Solved with sequelae, Conditions in improvement, Present and unchanged condition, Worsening, Death caused by this event]). Measurement time: daily throughout the period of admission to the ICU.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1) Virological diagnosis by PCR-RT of infection to SARS-CoV-2. 2) Patients with confirmed respiratory distress / multifocal interstitial pneumonia. 3) Need for oxygen therapy to maintain SO2> 93%. 4) Worsening of lung involvement, defined as one of the following criteria: a) Worsening of oxygen saturation > 3 percentage points or decrease in PaO2 > 10%, with stable FiO2 in the last 24 hours; b) Need to increase FiO2 in order to maintain stable SO2 or new need for mechanical ventilation in the last 24 hours; c) Increase in the number and / or extension of the lung consolidation areas. 5) Patients in whom a clinical condition prior to hyperinflammation is suspected, according to the following criteria: a) sustained fever above 38 combined with criteria 2 or 3 and 4; b) dyspnea requiring oxygen therapy by mask or nasal fork, to maintain an oxygen saturation above 93; c) polypnea greater than 25 ventilations per minute, requiring oxygen therapy by mask or nasal fork, to maintain an oxygen saturation above 93; d) choppy language that does not allow you to count to 10. 6) Express voluntariness of the patient, family member or impartial witness.

Exclusion criteria:

1) Known hypersensitivity to any of the components of the formulation. 2) Pregnancy or lactation.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

All patients meeting selection criteria

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Verena

Middle Name:

Lucila

Last Name:

Muzio Gonzalez

Specialty:

PhD in Biological Sciences; 1st degree specialist in Immunology.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72716022

Email :

verena.muzio@cigb.edu.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Maria

Middle Name:

del Carmen

Last Name:

Dominguez Orta

Specialty:

Graduated in Biochemistry; PhD in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Habana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72716022

Email :

mcarmen.dominguez@cigb.edu.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

"Pedro Kouri" Tropical Medicine Institute (IPK)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

25/04/2020

Postal address of Ethic Committee :

Novia del Mediodia avenue, KM 6 1/2, CP: 11400, La Lisa, Havana, Cuba

Telephone:

+53-72020425

Email:

daniel@ipk.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

35

Study completion date:

30/08/2020

Date of available results:

15/09/2020

Date of first publication:

15/10/2020

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000321

Date of Registration in Primary Registry:

22/06/2020

Record Verification Date:

2020/06/22

Next update date:

2021/06/22

Link to the spanish version:

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Registered Trials

Registration process

VIDA study

About the RPCEC

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